Influence of Whole Body Vibration Compared to Conventional Physiotherapy in Patients With Gonarthrosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Gregor Stein, University of Cologne
ClinicalTrials.gov Identifier:
NCT01037972
First received: December 22, 2009
Last updated: October 7, 2011
Last verified: October 2011
  Purpose

40 patients with osteoarthritis of the knee will be randomly assigned to conventional physiotherapy on the one and whole body vibration exercises on the other hand. The duration of the training will be 6 weeks, three times a week.

The outcome will be measured by WOMAC and SF-12 scores relating to pain and quality of life. The second outcome criteria will be a motion analysis and balance testing before and after the training.

The follow-up is 26 weeks.


Condition Intervention
Osteoarthritis
Behavioral: Conventional physiotherapy
Behavioral: Whole body vibration

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Influence of Whole Body Vibration Compared to Conventional Physiotherapy in Patients With Gonarthrosis

Resource links provided by NLM:


Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • Pain Reduction [ Time Frame: 6 weeks after inclusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Motion analysis [ Time Frame: 6 weeks after inclusion ] [ Designated as safety issue: No ]
  • Pain reduction [ Time Frame: 12 weeks after inclusion ] [ Designated as safety issue: No ]
  • Pain reduction [ Time Frame: 26 weeks after inclusion ] [ Designated as safety issue: No ]
  • Motion analysis [ Time Frame: 12 weeks after inclusion ] [ Designated as safety issue: No ]
  • Motion analysis [ Time Frame: 26 weeks after inclusion ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 6 weeks after inclusion ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 12 weeks after inclusion ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 26 weeks after inclusion ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: March 2010
Study Completion Date: October 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Whole body vibration Behavioral: Whole body vibration
3 times weekly 30 minutes of exercises on a whole body vibration device to strengthen muscular strength and improve muscular balance in the lower extremity.
Other Name: Galileo Whole body vibration
Conventional physiotherapy Behavioral: Conventional physiotherapy
3 times weekly 30 minutes of conventional physiotherapy to strengthen muscular strength and balance in the lower extremity.
Other Name: Galileo

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with osteoarthritis of the knee.

Criteria

Inclusion Criteria:

  • 30-80 years old
  • WOMAC 30-70 mm (VAS)
  • Gonarthrosis (Kellgren/Lawrence) II-III

Exclusion Criteria:

  • WOMAC >70 mm (VAS)
  • Endoprosthesis in lower extremity
  • BMI >40 kg/m2
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01037972

Locations
Germany
University Hospital of Cologne
Cologne, Germany, 50924
Sponsors and Collaborators
University of Cologne
Investigators
Principal Investigator: Kourosh Zarghooni, MD University of Cologne
Study Director: Gregor Stein, MD University of Cologne
  More Information

Additional Information:
No publications provided by University of Cologne

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Gregor Stein, Dr. med, University of Cologne
ClinicalTrials.gov Identifier: NCT01037972     History of Changes
Other Study ID Numbers: Galileo, 2009-017617-29
Study First Received: December 22, 2009
Last Updated: October 7, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by University of Cologne:
Galileo
Whole body vibration
Osteoarthritis
Knee
Physiotherapy

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 27, 2014